Container, Specimen Mailer And Storage, Non-Sterile
The non-sterile specimen mailer and storage container is a pathology device used to transport and store biological specimens safely during mailing or transit to laboratories. It is classified as FDA Class 1 under regulation 864.3250 in the Pathology specialty, and it is GMP exempt. Product code NNK does not require a 510(k) submission and is subject only to general controls, reflecting its low-risk nature as a non-sterile storage and transport device.
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Basic Information
- Product Code
- NNK
- Device Class
- FDA class 1
- Regulation Number
- 864.3250
- Medical Specialty
- Pathology
- Review Panel
- PA
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 187 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 187 registration numbers. Click on an entry to view related FDA registrations.